MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW STRATUS CS

Catalog Number 10453531

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Customer reported falsely high troponin results on the instrument.

Manufacturer Narrative

There was no harm to the patient due to this event.Siemens team investigated customer return patient sample.Investigation: a plasma sample from the patient sample in question was returned to the (b)(6) site - this sample was not from the initial draw but from the second draw.One (1) replicate of the plasma sample was tested on one (1) stratus cs analyzer (b)(4) using testpak lot 235033002.The initial result obtained was 3.82 ng/ml.A 500 ul of the plasma was then treated with a blocking agent (hbt) from (b)(4) which is composed of specific binders which inactivate heterophilic antibodies.The plasma sample incubated at rt for 1 hour with the blocking reagent and was then tested on the same stratus cs analyzer.The result obtained was 2.46 ng/ml.This result demonstrated a decrease in ctni concentration.When this ctni decrease is considered with what is stated in the product material for the blocking agent, which states if a patient sample is one with an extremely strong heterophilic interference, the blocking agent is unable to block all of the assay interference.Based on these results along with the negative vista result, it appears that there was heterophile antibody interference.Conclusion: along with a negative troponin result on the alternate instrument (siemens vista) at the customer site, internal testing concluded that heterophilic antibody interference caused the false positive troponin result.Treatment with heterophilic antibody blocker reduced the clinical result from 3.82 ng/ml to 2.46 ng/ml.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4827556
• MDR Text Key: 21555026
• Report Number: 1217157-2015-00071
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10453531
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR